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A Study of the Safety and Pharmacokinetics of MEGF0444A Administered to Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00909740
Recruitment Status : Completed
First Posted : May 28, 2009
Last Update Posted : May 9, 2012
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A administered by IV infusion to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.

Condition or disease Intervention/treatment Phase
Solid Cancers Drug: MEGF0444A Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MEGF0444A, Administered Intravenously to Patients With Advanced Solid Tumors
Study Start Date : May 2009
Primary Completion Date : October 2011
Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: 1 Drug: MEGF0444A
Intravenous escalating dose

Primary Outcome Measures :
  1. Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Days 1-21 of cycle 1 ]
  2. Incidence, nature, relatedness, and severity of adverse events [ Time Frame: Day 1 to study completion ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution [ Time Frame: Following administration of study drug ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on, or failed to respond to regimens or therapies known to provide clinical benefit

Exclusion Criteria:

  • Inadequate hematologic and organ function
  • Anti-cancer therapy within 4 weeks prior to initiation of study treatment
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
  • Active infection or autoimmune disease
  • Pregnancy (positive pregnancy test) or lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909740

Sponsors and Collaborators
Genentech, Inc.
Study Director: Louie Naumovski, M.D., Ph.D. Genentech, Inc.

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00909740     History of Changes
Other Study ID Numbers: MEF4693g
First Posted: May 28, 2009    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012

Keywords provided by Genentech, Inc.:
Solid Tumor